(85 days)
DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.
This appears to be a 510(k) Summary for a medical device (dental abutments) rather than a study report with acceptance criteria for an AI/ML powered device. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance data (mechanical testing, biocompatibility, sterilization validation, MRI compatibility). It explicitly states: "No clinical data were included in this submission."
Therefore, I cannot extract acceptance criteria or information about a study that proves the device meets those criteria in the context of an AI/ML device, as the provided text doesn't describe such a device or study.
If the request was based on a misunderstanding of the document's content, please clarify. If you're looking for general information on what would be included in such a study for an AI/ML device, I can provide a theoretical outline.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
Terrats Medical SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130
Re: K230143
Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 17, 2023 Received: January 18, 2023
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
K230143 510(k) Number (if known)
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
| Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connection | ||
| Legacy1 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, Legacy4 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| 5.2 | 4.5 | |
| Internal Conical Connection | ||
| InterActive | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.3 | 3.4 | |
| 5.0 | 3.4 | |
| Simply Iconic™ | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.2 | 3.0 | |
| 4.7 | 3.0 | |
| 4.7 | 3.4 | |
| 5.2 | 3.4 | |
| 5.7 | 3.4 |
Compatible Implant Systems
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary K231043 Terrats Medical SL DESS® Dental Smart Solutions February 27, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL |
|---|---|
| Carrer Mogoda, 75-99 | |
| Barberà del Vallès 08210 | |
| Barcelona, Spain | |
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD |
| Floyd G. Larson, MS, MBA | |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone +1 858-792-1235 | |
| Fax +1 858-792-1236 | |
| Email kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K222269, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K061319, Spectra Dental Implant System, Implant Direct, LLC K192221, Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy3, Legacy4 fixture-mounts, Implant Direct Sybron Manufacturing, LLC K130572, InterActive / SwishPlus 2 Implant System, Implant Direct Sybron Manufacturing LLC K201553, Simply Iconic™ Implants, Implant Direct Sybron Manufacturing LLC
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INDICATIONS FOR USE STATEMENT
DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
| Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connection | ||
| Legacy1 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, Legacy4 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| 5.2 | 4.5 | |
| Internal Conical Connection | ||
| InterActive | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.3 | 3.4 | |
| 5.0 | 3.4 | |
| Simply Iconic™ | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.2 | 3.0 | |
| 4.7 | 3.0 | |
| 4.7 | 3.4 | |
| 5.2 | 3.4 | |
| 5.7 | 3.4 |
Compatible Implant Systems
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.
A summary of the subject device abutment designs and the compatible OEM implants is provided in the table Summary of Subject Device Multi-Unit Abutment Designs on the following page.
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| Connections | Subject DeviceMulti-Unit Abutments | Implant-AbutmentPlatform Ø, mm | GingivalHeight, mm | CompatibleImplant DirectImplant Lines |
|---|---|---|---|---|
| Internal hex | Straight | 3.5 | 1 – 5 | Legacy1Legacy2simplyLegacy2Legacy3simplyLegacy3Legacy4 |
| Straight | 4.5 | 1 - 3 | ||
| 17° Angled | 3.5 | 2.5, 3.5 | ||
| 17° Angled | 4.5 | 2.5, 3.5 | ||
| 30° Angled | 3.5 | 3.5, 4.5 | ||
| 30° Angled | 4.5 | 3.5, 4.5 | ||
| Internal conical | Straight | 3.0 | 1.5 – 3.5 | InterActiveSimply Iconic™ |
| Straight | 3.4 | 1.5 – 4.5 | ||
| 17° Angled | 3.0 | 2.5, 3.5 | ||
| 17° Angled | 3.4 | 2.5, 3.5 | ||
| 30° Angled | 3.0 | 3.5, 4.5 | ||
| 30° Angled | 3.4 | 3.5, 4.5 |
Summary of Subject Device Multi-Unit Abutment Designs
The design dimensions and tolerances of subject device abutments and screws have been established on the basis of a contractual agreement and working relationship between Implant Direct and Terrats Medical SL to ensure that the abutments are designed to fit the corresponding Implant Direct implants listed above.
Multi Unit Abutments
The Multi-Unit Abutment is designed for attachment of multi-unit screw-retained restorations and is provided in three (3) designs, straight, angled 17°, and angled 30°. The design of the straight Multi-Unit Abutments is similar to that of straight Multi-Unit Abutments cleared in K222269 with the exception of the implant connections and platform diameters. The straight Multi-Unit Abutment is provided only in a non-engaging, threaded design that attaches directly to the implant. All straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm. Straight Multi-Unit Abutments are provided for Implant Direct internal hex implants with 3.5 mm and 4.5 mm platform diameters, and for Implant Direct internal conical implants with 3.0 mm platform diameters. The gingival height of the straight Multi-Unit Abutment ranges from 1.5 mm to 5.5 mm.
The angled Multi-Unit Abutments are provided in an engaging design that requires an abutment screw, with angulations of 17° and 30°. The angled Multi-Unit Abutments are provided for the same Implants as the straight Multi-Unit Abutments (internal hex implants with 3.5 mm platform diameters, and internal conical implants with 3.0 mm and 3.4 mm platform diameters). All angled Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with gingival heights from 2.5 mm. The designs of the angled Multi-Unit Abutments are similar to those of the angled Multi-Unit Abutments cleared in K222269. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
Screws
This submission includes three (3) abutment screws to be used with the subject device abutments. The screws have a hex or hexalobular instrument interface and are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
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PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
sterilization validation according to ISO 17665-1 and ISO 17665-2, referenced from K22269;
biocompatibility according to ISO 10993-5 and ISO 10993-12, referenced from K22269;
non-clinical analysis performed to evaluate the metallic subject devices and compatible dental implants in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque; and
static compression and compression fatigue testing of worst-case constructs comprising the subject device Multi Unit Angled Abutments and compatible OEM implants in conformance with ISO 14801.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device abutments are substantially equivalent in intended use to the primary predicate device K222269. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of K222269, except for the list of compatible OEM implants. An additional difference between the IFUS of the subject device and that of the primary predicate K22269 is the language in K22269 describing the requirement of a validated milling center for CAD-CAM abutments. This language is not applicable to the subject device abutments. All reference devices identified are for OEM implant body compatibilities.
The range of dimensions of the subject device abutment-implant platform diameter, prosthetic platform diameter, gingival height, and abutment angulation, is encompassed by the corresponding multiunit abutments in the primary predicate device K222269.
All subject device components are provided non-sterile and are to be sterilized by the same moist heat cycle recommended in the primary predicate K222269. The subject devices are packaged in either a PETG blister pack or a PET bag, the same packaging as cleared in K222269.
The risks associated with use of the subject device angled multi-unit abutments in combination with the compatible implants are mitigated by mechanical testing performed according to ISO 14801.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device and the primary predicate device encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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| Indications for Use Statement | |||
|---|---|---|---|
| Subject Device | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | ||
| K231043 | Compatible Implant Systems | ||
| DESS Dental Smart Solutions | Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm |
| Terrats Medical SL | Internal Hex Connection | ||
| Legacy1 | 3.7 | 3.5 | |
| 4.2 | 3.5 | ||
| 4.7 | 4.5 | ||
| Legacy2, simplyLegacy2,Legacy3, simplyLegacy3,Legacy4 | 3.7 | 3.5 | |
| 4.2 | 3.5 | ||
| 4.7 | 4.5 | ||
| 5.2 | 4.5 | ||
| Internal Conical Connection | |||
| 3.2 | 3.0 | ||
| 3.7 | 3.0 | ||
| InterActive | 4.3 | 3.4 | |
| 5.0 | 3.4 | ||
| 3.2 | 3.0 | ||
| 3.7 | 3.0 | ||
| 4.2 | 3.0 | ||
| Simply Iconic™ | 4.7 | 3.0 | |
| 4.7 | 3.4 | ||
| 5.2 | 3.4 | ||
| 5.7 | 3.4 | ||
| Primary Predicate Device | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | ||
| K222269 | All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture. | ||
| DESS Dental Smart Solutions | Compatible Implant Systems | ||
| Terrats Medical SL | Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform |
| PRIMA CONNEX(Internal TiLobe, Tapered & Straight) | 3.3, 3.5 | 3.5 | |
| 4.0, 4.1 | 4.1 | ||
| 5.0 | 5.0 | ||
| GENESIS(Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 | |
| 4.5 | 4.5 | ||
| 5.5, 6.5 | 5.5/6.5 | ||
| MOLARIS TILOBEMAXX(Internal TiLobe) | 7 | 5.7 | |
| 8 | 6.5 | ||
| 9 | 7.5 | ||
| MOLARIS I-HEXMRT(Internal Hex) | 7 | 5.7 | |
| 8 | 6.5 | ||
| 9 | 7.5 | ||
| PALTOP ADVANCED CLASSIC(Internal Hex) | 3.25 | NP (3.25) | |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | ||
| PALTOP ADVANCED PLUS(Internal Hex) | 3.0, 3.25 | NP (3.25) | |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | ||
| 6.0 | WP (6.0) | ||
| PALTOP DYNAMIC(Internal Hex) | 3.0, 3.25 | NP (3.25) | |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | ||
| 6.0 | WP (6.0) | ||
| PALTOP DYNAMIC CONICAL(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |
Table of Substantial Equivalence – Indications for Use Statement
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Table of Substantial Equivalence – Technological Characteristics
| Subject DeviceK231043DESS Dental Smart SolutionsTerrats Medical SL | Primary Predicate DeviceK222269DESS Dental Smart SolutionsTerrats Medical SL | |
|---|---|---|
| Reason for Predicate Device | Not applicable | Abutment designs, materials, sterilization |
| Product Codes | NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of theedentulous mandible or maxilla | Functional and esthetic rehabilitation of theedentulous mandible or maxilla |
| Abutment Designs | ||
| Abutment Types | Multi-Unit, Straight (0°), 17°, 30° | Multi-Unit, Straight (0°), 17°, 30°Ti BaseAURUM BasePremilled Blank |
| Prosthesis Attachment | Screw Retained | Cement-retainedScrew Retained |
| Restoration | Multi-unit | Single-unitMulti-unit |
| Prosthetic Interface Connections | Internal | Internal |
| Abutment/Implant Platform Diameter | 3.0 - 4.5 mm | MUAs: 3.25 mm – 7.5 mm |
| Prosthetic Platform Diameter | 4.8 mm | MUAs: 4.8 mm, 6.0 mm |
| Gingival Height | 1 mm - 5 mm | MUAs: 1 mm – 5 mm |
| Abutment Angulation, degrees | Straight (0°), 17°, 30° | MUAs: Straight (0°), 17°, 30° |
| Abutment Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Abutment Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| How Provided | ||
| Sterilization | Non-sterile | Non-sterile |
| Usage - All Components | Single patient, single use | Single patient, single use |
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)